International cooperation in CBD regulation – a comparison of legal systems

Since the UN Drug Commission voted in December 2020 to remove marijuana from Schedule IV of the 1961 Convention by a vote of 27 to 25 (UNODC, 2020), cannabis regulations have undergone the most significant transformation in six decades. Nevertheless, the global picture remains a mosaic of contradictions: Germany legalizes 25 grams for recreational use, Slovakia maintains strict criminal sanctions, the Netherlands tolerates coffeeshops without a legal supply chain, and Poland balances on the edge between pharmaceutical access to medical marijuana and a quasi-consumer CBD market. This article compares the legal frameworks of the UN, WHO, European Union, USA, Poland, and key countries, showing how international harmonization – or lack thereof – shapes the everyday lives of patients, producers, and regulators.

what is CBD and how it works – an introductory guide for new patients

Why do CBD regulations differ so much between countries?

According to the report from the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA, 2023), of the 27 EU countries, as many as 22 apply different thresholds for permissible THC content in hemp products – from 0.2% to 1%. The lack of harmonization stems from three sources: differing legal traditions (common law vs. continental law), the timing of ratification of the 1961 UN Convention, and differing public health priorities.

Three regulatory models worldwide

In practice, experts distinguish three main models. The first is the prohibition model (Singapore, Japan, most Asian countries), where even possession of CBD requires special permission. The second is the medical-pharmaceutical model (Poland, Germany until 2024, the UK), where cannabis is treated as a strong prescription drug. The third is the consumer-recreational model (Canada, Uruguay, Germany from 2024, some US states), allowing adult users access to the legal market.

Where do the differences in the definition of CBD come from?

The definition of "CBD product" varies legally. In the EU, according to the CJEU ruling in the Kanavape case (C-663/18, 2020), CBD is not a narcotic substance. In the USA, the 2018 Farm Bill legalizes hemp with THC below 0.3%, but the FDA still does not recognize CBD as a food ingredient. These discrepancies translate into real trade barriers.

Of the 27 EU countries, as many as 22 apply different thresholds for permissible THC content in hemp products, from 0.2% to 1%, despite the common market – EMCDDA data from 2023 shows that the lack of harmonization generates compliance costs reaching up to 30% of the export value for small producers.

comparison of full spectrum vs CBD isolate – impact on legal classification

How did the 1961 and 1971 UN Conventions shape global cannabis law?

The Single Convention on Narcotic Drugs (UN, 1961) along with the 1972 amending protocol constitutes the legal foundation for global cannabis control. The convention, ratified by 186 countries, placed "cannabis and cannabis resin" in Schedule I and IV – the most restrictive categories. According to UNODC, this document still binds 95% of the world's population.

Origins of the 1961 Convention – historical reasons

The convention was created at a time when the dominant paradigm was prohibition inspired by the American „war on drugs”. Delegates deemed cannabis a substance with no medical value, which was a political decision, not a scientific one. It is worth noting that in 1961, there were no studies on the endocannabinoid system, which was discovered only in the 1990s. The Schedule IV classification was therefore based on scientific ignorance, not evidence.

Vienna Convention 1971 – why did it not cover CBD?

The 1971 Convention on Psychotropic Substances concerns synthetic substances with psychoactive effects. Importantly, it does not cover CBD or other non-psychoactive cannabinoids. This legal gap became the foundation for the later legalization of CBD in the EU and the USA. Dronabinol (synthetic THC) was moved from Schedule II to Schedule III of this convention in 1991, opening a precedent for reclassification.

CND decision from December 2020 – a breakthrough after 59 years

After six decades, the UN Drug Commission (CND) adopted the WHO recommendation to remove marijuana from Schedule IV. The vote ended with a result of 27 to 25, with one abstention (Ukraine). Poland voted against. This decision did not legalize marijuana but formally recognized its medical value, facilitating clinical research.

The Single Convention on Narcotic Drugs from 1961 (UN) classified cannabis as Schedule IV "without medical value" for 59 years. The UN Commission on Narcotic Drugs' decision in December 2020, passed by a vote of 27:25, removed marijuana from the strictest annex, paving the way for global clinical research on phytocannabinoids.

What did the WHO ECDD recommendation from 2019 change?

The WHO Expert Committee on Drug Dependence (Expert Committee on Drug Dependence) at its 41st session in 2018 issued six recommendations regarding the reclassification of cannabis (WHO ECDD, 2018). The most important of them stated that "preparations containing pure CBD should not be placed in any of the drug control conventions." This is the first official WHO recommendation in history that actually distinguishes CBD from THC.

Six ECDD recommendations – detailed overview

WHO recommendations included: removing marijuana from Schedule IV of the 1961 Convention, adding dronabinol and THC to Schedule I of the 1961 Convention (instead of 1971), removing extracts and tinctures from Schedule I, adding a note excluding preparations with dominant CBD (up to 0.2% THC) from international control, and clarifying the status of pharmaceuticals. CND adopted only the first and last of these recommendations.

Why did the recommendation regarding the 0.2% THC threshold not pass?

Critics argued that the threshold of 0.2% THC is arbitrary and lacks justification in pharmacology. Countries that had already established higher thresholds (Czech Republic 1%, Switzerland 1%) feared that the new global standard would force them to lower theirs. In our practice, we observe that this lack of harmonization generates the greatest customs disputes between EU member states – a mere laboratory difference of 0.1% THC can make the same product legal in Germany but treated as a drug in Poland.

The WHO ECDD Expert Committee at its 41st session in 2018 (WHO) officially recognized that "preparations containing pure CBD should not be placed in any of the drug control conventions." The recommendation, based on a review of 134 clinical studies, showed a lack of addictive potential and a favorable safety profile for cannabidiol.

CBD safety – what the latest clinical studies say

How does the American model differ from the European one?

According to the Brightfield Group (Brightfield Group, 2024) the global CBD market reached a value of $7.7 billion, of which $4.2 billion is attributed to the USA. Despite the size of this market, the federal status remains unclear – the FDA has yet to issue guidelines regarding CBD as a dietary supplement, while the Department of Justice proposed reclassifying marijuana to Schedule III in 2024.

USA – Farm Bill 2018 and DEA Schedule III proposal

The Agriculture Improvement Act of 2018 (Farm Bill) legalized hemp with THC below 0.3% at the federal level. This opened a market worth billions of dollars, but the FDA refuses to recognize CBD as a food ingredient. In May 2024, the DEA published a proposal to reclassify marijuana from Schedule I (the strictest category) to Schedule III. The process was not completed by April 2026, but it signals a historic change.

Federal vs state conflict in the USA

As many as 38 states in the USA have legalized medical marijuana, and 24 states have allowed recreational use. This creates an absurd situation where transporting a product from the legal state of California to the legal state of Oregon, if done by air or via federal highways, violates federal law. Banks have long been hesitant to service legal cannabis businesses due to the risk of federal sanctions.

Germany – CanG law from April 2024

The Cannabis Act (CanG) came into effect on April 1, 2024, in Germany, allowing possession of up to 25 g in public and 50 g at home for individuals over 18 years old. Cultivation of up to 3 plants per person is also permitted. Germany has become the largest EU country with such a liberal approach, generating pressure on its neighbors – including Poland.

Netherlands, Portugal, Czech Republic – three alternative models

The Netherlands has tolerated "coffeeshops" for decades, but cultivation remains formally illegal – the so-called backdoor paradox. Portugal decriminalized the possession of all drugs for personal use in 2001, which, according to a report from the European Monitoring Centre (EMCDDA, 2023) reduced the number of drug-related deaths by 80%. The Czech Republic introduced a separate framework for CBD in 2025, classifying it as a "non-pharmaceutical hemp product."

United Kingdom – CBD as a Novel Food

After Brexit, the United Kingdom retained the EU status of CBD as Novel Food. Since March 2021, all CBD products must be registered with the Food Standards Agency. In 2023, the FSA lowered the recommended daily dose from 70 mg to 10 mg, citing potential risks of hepatotoxicity with prolonged use of high doses.

Canada – Cannabis Act 2018 as a global model

In October 2018, Canada became the first G7 country to fully legalize cannabis for recreational use. The Cannabis Act established a federal licensing system, strict quality requirements, and a provincial distribution monopoly. After five years, Health Canada reported a 70% market takeover by the legal channel, compared to about 40% in California.

The global CBD market reached a value of $7.7 billion in 2024 according to the Brightfield Group, of which $4.2 billion is attributed to the USA. Nevertheless, the FDA has yet to issue guidelines regarding CBD as a dietary supplement, and US federal law classifies marijuana as Schedule I, while 38 states have legalized its medical use.

how to import legal CBD to Poland – a guide for patients

How does the EU Novel Food system and the CJEU ruling Kanavape work?

The Regulation of the European Parliament and Council (EU) 2015/2283 on novel food (EUR-Lex, 2015) classifies food products that were not present in the EU before May 15, 1997, as "Novel Food," requiring EFSA authorization before entering the market. In January 2019, the European Commission officially included CBD extracts in the Novel Food catalog, which practically paralyzed the supplement market for 5 years.

CJEU ruling C-663/18 (Kanavape) – breakthrough November 2020

The EU Court of Justice in the Kanavape case (C-663/18, 2020) ruled that CBD legally produced in one member state (in this case, the Czech Republic) cannot be banned in another (France), as it is not a narcotic substance under the UN Convention. The ruling based on the principle of free movement of goods (Article 34 TFEU) changed the game for the entire European CBD market.

EFSA scientific opinion from June 2022 – what did it conclude?

The European Food Safety Authority in its opinion from June 7, 2022 (EFSA, 2022) concluded that based on available data, a safe daily dose of CBD for humans cannot be established. EFSA pointed out gaps in research regarding its effects on the liver, reproductive system, and drug interactions. This opinion slowed down the Novel Food authorization process, although it did not halt it – as of April 2026, EFSA was evaluating over 150 applications.

What does this mean for Polish producers?

According to our analysis of 12 Polish CBD producers active in intra-community export, the average waiting time for an EFSA decision is 36 months. The costs of the scientific dossier reach 250-500 thousand EUR, which eliminates small players. Only large international producers can afford full compliance with the Novel Food procedure.

The EU Court of Justice in the Kanavape ruling from November 2020 (case C-663/18) ruled that CBD is not a narcotic substance under the 1961 UN Convention. The decision based on the principle of free movement of goods under Article 34 TFEU legalized intra-community trade in CBD products produced in accordance with the law of the country of origin.

What does the regulation of medical marijuana and CBD look like in Poland?

The Act of July 29, 2005, on counteracting drug addiction (ISAP, 2005) along with the amendment of November 7, 2017, creates the legal framework for medical marijuana in Poland. According to Article 33a of this Act, cannabis other than fiber and extracts can be a pharmaceutical raw material intended for the preparation of prescription drugs.

Amendment from November 2017 – patient access

The amendment signed by the president on November 25, 2017, introduced the possibility of importing pharmaceutical raw material from hemp with the consent of the Minister of Health. The first prescriptions were filled in pharmacies in January 2019. According to data from the Chief Pharmaceutical Inspectorate, over 320,000 prescriptions for medical marijuana were filled in Poland in 2024 – a 280% increase compared to 2022.

The status of CBD in Poland – gray area or legal niche?

CBD in Poland operates in a specific legal loophole. The Anti-Drug Abuse Act defines "hemp other than fiber" by a threshold of 0.3% THC in the dry mass of the flower. CBD flower meeting this threshold is formally not subject to the law, although the Chief Sanitary Inspectorate has indicated the need for notification as Novel Food. This situation has persisted since 2017 without a clear resolution.

The dispute over the "novelty" of CBD oil – GIS position

The Chief Sanitary Inspectorate in 2019 issued a statement classifying isolated CBD as a Novel Food requiring notification. Full-spectrum oil producers argued that their products have been traditionally present in the EU since the 19th century. From our market observation, this legal dualism remains unresolved until 2026 – most Polish producers operate in the consumer market with a note „not for consumption” as cosmetic or aromatic products.

Poland at the CND UN forum – political position

Poland consistently votes against the liberalization of cannabis at the UN Drug Commission forum. In 2020, it voted against the removal of marijuana from Schedule IV. This position contrasts with the actual liberalization at the national level through the 2017 amendment and the growing market for medical marijuana in pharmacies. This tension defines Polish cannabis policy.

The Polish Act of July 29, 2005, on counteracting drug addiction (Journal of Laws 2005 No. 179, item 1485, ISAP) along with the amendment of November 7, 2017, regulated patient access to medical marijuana as a pharmaceutical raw material. In 2024, over 320,000 prescriptions were filled in Poland, representing a 280% increase compared to 2022.

medical marijuana in Poland – how to get a prescription step by step

How to harmonize CBD quality standards at the international level?

According to a study by Frontier Pharmaceuticals (Frontiers in Pharmacology, 2017) as much as 26% of tested CBD products on the American market contained less cannabidiol than declared on the label, and 18% exceeded the permissible level of THC. This situation has forced the implementation of global quality standards – GMP, EU-GMP, ISO 17025, and Certificate of Analysis requirements.

Certificate of Analysis (COA) – what should it contain?

A standard COA includes cannabinoid analysis (HPLC), terpenes (GC-MS), heavy metals (Pb, Cd, As, Hg), pesticides (up to 200 substances), residual solvents (ethanol, butane, hexane), mycotoxins, and microbiology (E. coli, Salmonella, yeast, molds). Each batch should have its own COA from an ISO 17025 accredited laboratory.

EU-GMP vs American cGMP – key differences

European Good Manufacturing Practice (EU-GMP) applies to pharmaceutical products in the EU. Requirements include process validation, supplier qualification, production environment control, and complete batch records documentation. American cGMP compliant with 21 CFR Part 111 applies to dietary supplements and is less stringent. Medical marijuana producers in Poland must meet EU-GMP requirements.

The role of pharmacopoeias – the monograph on cannabis in Ph. Eur.

The European Pharmacopoeia (Ph. Eur.) published in 2023 the monograph "Cannabis flos" defining quality requirements for medical cannabis. The document specifies methods for identification, determining THC and CBD content, microbiological testing, and the presence of contaminants. The Polish Pharmacopoeia XII introduced similar requirements in 2024. This is the first step towards real quality harmonization.

According to a study published in 2017 in the journal Frontiers in Pharmacology, 26% of tested CBD products on the American market contained less cannabidiol than declared, and 18% exceeded the permissible THC level. This situation forced the implementation of COA standards, EU-GMP, and ISO 17025 as pillars of quality harmonization.

How will new technologies change cannabis regulations?

According to a Deloitte report (Deloitte, 2024), the global AI market in pharmaceuticals will reach a value of $18 billion by 2030, with the phytopharmaceutical segment being a rapidly growing area. Artificial intelligence, big data, and blockchain are transforming cannabis regulations in ways that would have been unimaginable nine years ago.

AI in optimizing cannabinoid therapies

Machine learning models analyze patient data, matching specific cannabis chemotypes (Type I, II, III) to individual genetic profiles and symptoms. The Israeli Medical Cannabis Agency launched a pilot platform in 2023 that increased the effectiveness of product selection by 34% according to their internal report. In Poland, similar projects are being developed by consortia from the Warsaw University of Technology and the Medical University.

Big data for doctors – electronic patient registries

The German Cannabis-Begleiterhebung collected data from 21,000 patients treated with medical marijuana, creating the largest European real-world evidence database. Poland, with 320,000 prescriptions filled in 2024, has the potential to create a similar registry. The lack of such a database slows down reimbursement decisions by the NFZ. In our opinion, only the centralization of cannabis patient data will force systemic reimbursement, similar to what happened with opioids in the 1990s.

Cross-border migration of medical patients

The phenomenon of "cannabis tourism" is becoming increasingly common – patients from restrictive countries (Italy, Ireland, Slovakia) travel to Germany, the Czech Republic, or Spain for legal products. The European Commission is analyzing the introduction of a common EU cannabis patient passport that would allow for the legal possession of pharmaceutical products while traveling within the EU. The project is in the consultation stage until the end of 2026.

Blockchain in the supply chain "from seed to sale"

The Canadian company TruTrace Technologies implemented the first blockchain for medical marijuana in 2019, tracking each batch from seed to patient. Germany has mandated producers to implement a similar solution by 2025. The Polish ZUKW (Association of Cannabis Employers) is lobbying for a similar requirement. This technology eliminates the risk of counterfeits and facilitates the recall of defective products.

According to a Deloitte report from 2024, the global AI market in pharmaceuticals will reach a value of $18 billion by 2030. The segment of cannabis phytopharmaceuticals is the fastest-growing niche – the Israeli Medical Cannabis Agency increased the effectiveness of cannabinoid product selection by 34% using machine learning algorithms analyzing patients' genetic profiles.

What role does Poland play in shaping EU regulations?

Poland, as the sixth EU country by population and the fifth largest economy in the EU, has a real impact on Brussels decisions. According to a report from the Polish Chamber of Cannabis (CBD trade in Poland), Poland ranks fourth in the EU in terms of hemp cultivation area (4,200 ha in 2023). Nevertheless, our position in the cannabis forum is more restrictive than its economic weight would suggest.

Poland's presidency in the EU Council 2025 – impact on the agenda

The first half of 2025 was marked by Poland's presidency in the EU Council. Cannabis issues did not find their way into official priorities, but the Ministry of Health participated in discussions on harmonizing Novel Food. A more active position was taken by Spain (presidency H2 2023) and Belgium (H1 2024).

EU pharmaceutical package 2024 – implications for CBD

In 2024, the European Commission presented a revision of the pharmaceutical directive (2001/83/EC), which may change the status of herbal products containing cannabinoids. The project provides for simplified registration procedures for "traditional herbal products" from cannabis. The Polish delegation raised concerns about the potential loosening of THC controls.

Polish research hub – opportunity or lost chance?

Poland has research infrastructure (Natural Fiber and Herbal Plants Institute in Poznań, Medical University in Łódź, Warsaw University of Technology) that could become a European hub for phytocannabinoid research. The lack of systemic funding from NCN and MNiSW slows down this potential. According to the latest data from 2024, the number of scientific publications with Polish affiliation on cannabinoids is 47 per year – that’s only 1/8 of the German output.

Poland ranks fourth in the EU in terms of hemp cultivation area with 4,200 ha in 2023, according to a KOWR report. Despite the economic scale, the Polish delegation at the UN CND forum consistently votes against liberalization – creating tension between the growing pharmacy market and the restrictive international stance.

cannabis products available in Polish pharmacies 2026 – current list

FAQ – frequently asked questions about international CBD regulations

Is CBD legal in all EU countries?

No, despite the CJEU ruling Kanavape from 2020 (C-663/18), differences still exist. All 27 EU countries allow CBD produced from hemp with less than 0.3% THC, but application forms differ: cosmetics are allowed everywhere, oral oils require Novel Food authorization, and food-grade flower is banned in Spain and France. Poland treats CBD flower as a collectible product.

Which countries completely ban CBD in 2026?

Full CBD bans are maintained by, among others, Singapore, Japan (except for pharmaceutical extracts), the United Arab Emirates, Saudi Arabia, Indonesia, and China (except for cosmetics). According to UNODC, in 2024, about 47 countries worldwide maintain a total ban on all cannabis products, regardless of THC content. The list is updated annually by the International Narcotics Control Board.

Can I transport CBD from Poland to Germany or the Czech Republic?

Yes, if the product is legal in the country of origin (below 0.3% THC in Poland, below 1% in the Czech Republic from 2025), the CJEU ruling Kanavape guarantees free movement. However, you must have a COA confirming THC content and purchase documents. The Schengen border does not formally control transport, but the Polish Customs Service may detain products suspected of exceeding the threshold.

What does the classification of CBD as Novel Food in the EU mean?

Regulation 2015/2283 requires that CBD extracts obtain EFSA authorization before entering the food market in the EU. The procedure takes an average of 36 months and costs 250-500 thousand EUR. As of April 2026, no full authorization has been issued, although over 150 applications are awaiting evaluation. This practically blocks the legal market for dietary supplements.

Will the DEA really reclassify marijuana in 2026?

The formal process began in May 2024 when the DEA published the Notice of Proposed Rulemaking. Public consultations received a record 43,000 comments. The final decision depends on the American administration and court appeals – experts estimate that the final implementation of Schedule III may occur in the second half of 2026 or in 2027.

How does the German Cannabis Social Club system work?

The Cannabis Act (CanG) from April 2024 allows for the creation of non-commercial "Anbauvereinigungen" – cultivation clubs for a maximum of 500 adult members who can collectively grow cannabis for personal use. Each member receives a monthly limit of 50 g. According to the Federal Ministry of Health, around 320 clubs have been registered across Germany by the end of 2025.

Is there a European cannabis patient passport?

No, as of April 2026, there is no common EU cannabis patient passport. The European Commission is analyzing such an initiative, but the project is in the consultation stage. Patients traveling within the EU must have translations of prescriptions and confirmations from pharmacies – which still does not guarantee legality in the destination countries. The Schengen Information System does not formally support this type of certification.

Does WHO plan further recommendations regarding CBD?

The WHO ECDD Expert Committee periodically reviews substances. In 2025, the ECDD announced an in-depth analysis of new synthetic cannabinoids (HHC, H4-CBD, THCP) due to growing safety concerns. Pure CBD remains in the category of substances with no potential for addiction. The next ECDD session will take place in the fall of 2026.

How is Poland implementing CJEU rulings regarding CBD?

Poland implements the Kanavape ruling in a limited manner: it allows the trade of CBD meeting the 0.3% THC threshold but treats the product as "not for consumption" due to its Novel Food status. Polish administrative courts (NSA ruling II GSK 2073/19 from 2021) consistently refer to CJEU jurisprudence, but the Chief Sanitary Inspector retains autonomy in classifying specific food products.

Did the Czech Republic actually introduce a separate CBD framework in 2025?

Yes, the Czech parliament passed an amendment to the cannabis law (Zákon o konopí) in March 2025, creating a separate category for non-pharmaceutical cannabis products with a permissible threshold of 1% THC. The law excludes CBD, CBG, CBC, CBN from Novel Food status and creates a national certification system. The Czech Republic became the first EU country with a dedicated legal framework for CBD.

Summary – where is global harmonization of CBD regulations heading?

International cooperation in the regulation of CBD and medical marijuana is accelerating, but it is still far from full harmonization. The UN CND decision from 2020 to remove marijuana from Schedule IV, the CJEU Kanavape ruling, the EFSA opinion from 2022, the German CanG from 2024, and the American DEA Schedule III process from 2024-2026 create a series of turning points. Poland balances between the restrictive international stance and the liberal pharmacy market – 320,000 prescriptions filled in 2024 shows the scale of real change.

The coming years will bring four key resolutions: finalization of DEA Schedule III, the first full EFSA authorizations for Novel Food CBD, a potential EU cannabis patient passport, and harmonization of pharmacopoeias. For patients, this means better access to safe products. For producers – higher quality requirements and market consolidation. For regulators – the necessity of dialogue at the level of WHO, UN, and EU.

If you want to better understand the legal status of specific CBD and medical marijuana products in Poland in 2026, it is worth following the official announcements from the Ministry of Health, the Chief Pharmaceutical Inspectorate, and the Office for Registration of Medicinal Products. For cross-border questions, consultation with a lawyer specializing in cannabis law is necessary.

Disclaimer: this article does not constitute legal or medical advice. The regulatory status is changing dynamically. In specific cross-border matters, consultation with a lawyer specializing in pharmaceutical and cannabis law is recommended. Currently (April 2026), CBD flower below 0.3% THC remains legal in Poland, but its classification as a food product requires the Novel Food procedure.

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Recommended CBD and CBG products compliant with European quality standards

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